REGULATORY UPDATE: Blood Community Submits Comments to FDA on Draft Guidances

AABB recently joined partner organizations in the blood community to submit comments to the Food and Drug Administration docket in response to two recent draft guidance documents.

In response to “Blood Pressure and Pulse Donor Eligibility Requirements: Compliance Policy; Draft Guidance for Industry,” issued May 2022, AABB and America’s Blood Centers (ABC) submitted joint comments recommending that FDA not take regulatory action regarding the requirements for performing pre-donation blood pressure and pulse measurement. The organizations based this recommendation on an absence of science supporting the role of pre-donation blood pressure and pulse in risk mitigation. AABB and ABC also outlined several suggestions to further reduce regulatory burden in the event that FDA intends to take regulatory action with respect to the requirements to determine donor eligibility based on blood pressure and pulse measurement.

Additionally, AABB, ABC and the American Red Cross submitted joint comments to the FDA docket on the May 2022 draft guidance for industry “Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirement.” In these comments, the organizations expressed their support for the regulatory relief outlined in the guidance but asked FDA to reconsider the requirement to report annually the number and type of donations released under the conditions outlined in the guidance.  The comments recommended that FDA allow the review and monitoring of error rates and corrective action to be conducted by FDA investigators during the inspection process.

AABB members may contact regulatory@aabb.org with questions.